FDA 510(k) Application Details - K152835

Device Classification Name	Enzymatic Method, Creatinine   More FDA Info for this Device
510(K) Number	K152835
Device Name	Enzymatic Method, Creatinine
Applicant	TECO DIAGNOSTICS, INC. 1268 N. LAKEVIEW AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	YUNYUAN VIVIAN WANG Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	JFY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2015
Decision Date	03/07/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review